COVID-19CTC REGISTRYNCT04391920
Registry of CytoSorb Therapy in COVID-19 ICU Patients
An observational study of COVID-19, run by CytoSorbents, Inc at 7 sites in United States.
Trial summary
The CTC Registry collects patient-level clinical data on CytoSorb hemoadsorption provided to COVID-19 ICU patients via integration of the CytoSorb device into ECMO, CRRT, or hemoperfusion extracorporeal circuits. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- CytoSorb 300 mL device
- Type of treatment
- Medical device
- How many people
- 138 participants
- Where
- 7 sitesUnited States
- Study dates
- 28 Aug 2020to 20 Jan 2022
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COVID-19 ICU patients receiving CytoSorb hemoadsorption via integration of the CytoSorb device into ECMO, CRRT, or hemoperfusion extracorporeal circuits.
Who may be able to join
- Confirmed COVID-19
- Provision of CytoSorb therapy per Instructions for Use (IFU) of the CytoSorb device.
Who cannot join
- CytoSorb therapy for diseases other than COVID-19
- Survival unlikely within 24 hours (for prospectively enrolled patients)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Medical Center of Aurora
Aurora, Colorado, 80012
University of Chicago Medicine
Chicago, Illinois, 60637
Franciscan Health Indianapolis
Indianapolis, Indiana, 46237
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
West Virginia University
Morgantown, West Virginia, 26506
New York University Medical Center
New York, New York, 10016
Baptist Memorial Hospital
Southaven, Mississippi, 38671
About this study
Official title: Registry of CytoSorb Therapy in COVID-19 ICU Patients (CTC REGISTRY): Registry of Patient-level Clinical Data on CytoSorb Hemoadsorption Provided Via Integration of the CytoSorb Device Into Extracorporeal Membrane Oxygenation (ECMO), Continuous Renal Replacement Therapy (CRRT), or Hemoperfusion Extracorporeal Circuits in COVID-19 ICU Patients
The CTC Registry collects patient-level clinical data on CytoSorb hemoadsorption provided to COVID-19 ICU patients via integration of the CytoSorb device into ECMO, CRRT, or hemoperfusion extracorporeal circuits. The intent of the registry is to gain understanding on how CytoSorb hemoadsorption provides clinical benefit to COVID-19 ICU patients.
- Conditions
- COVID-19
- Being tested
- CytoSorb 300 mL device
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytoSorb 300 mL deviceDevice
CytoSorb hemoadsorption provided via integration of the CytoSorb device into ECMO, CRRT, or hemoperfusion extracorporeal circuits.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 ICU Patients | Not described Receives: Device: CytoSorb 300 mL device |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU mortality
Measured: From the date of start of CytoSorb use until the date of ICU discharge or date of death, whichever comes first, assessed up to 1 year
Secondary outcomes (5)
Duration of ECMO after start of CytoSorb
Measured: From the date of start of CytoSorb use until the date of cessation of ECMO or date of death, which ever comes first, assessed up to 1 year
Duration of mechanical ventilatory support after start of CytoSorb
Measured: From the date of start of CytoSorb use until the date of cessation of mechanical ventilatory support or date of death, which ever comes first, assessed up to 1 year
Duration of pharmacologic hemodynamic support after start of CytoSorb
Measured: From the date of start of CytoSorb use until the date of cessation of pharmacologic hemodynamic support or date of death, which ever comes first, assessed up to 1 year
Change in serum concentrations of inflammatory biomarkers after start of CytoSorb
Measured: From the day before start of CytoSorb use until the day after cessation of CytoSorb use
Change in Pa02/Fi02 ratio after start of CytoSorb
Measured: From the day before start of CytoSorb use until the day after cessation of CytoSorb use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start28 Aug 2020
- Primary completion20 Jan 2022
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 138 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- CytoSorbents, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CytoSorbents Europe GmbH
- Responsible party
- Sponsor
- Investigators
- Peter Nelson, MD, Study director, CytoSorbents Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391920
- Sponsor's protocol ID
- 2020-001
- Other IDs
- FDA EUA
- Acronym
- CTC REGISTRY
- Status last verified
- Jan 2022
- First submitted
- 12 May 2020
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Hayanga JWA, Song T, Durham L, Garrison L, Smith D, Molnar Z, Scheier J, Deliargyris EN, Moazami N. Extracorporeal hemoadsorption in critically ill COVID-19 patients on VV ECMO: the CytoSorb therapy in COVID-19 (CTC) registry. Crit Care. 2023 Jun 19;27(1):243. doi: 10.1186/s13054-023-04517-3.
PubMed 37337243Song T, Hayanga J, Durham L, Garrison L, McCarthy P, Barksdale A, Smith D, Bartlett R, Jaros M, Nelson P, Molnar Z, Deliargyris E, Moazami N. CytoSorb Therapy in COVID-19 (CTC) Patients Requiring Extracorporeal Membrane Oxygenation: A Multicenter, Retrospective Registry. Front Med (Lausanne). 2021 Dec 20;8:773461. doi: 10.3389/fmed.2021.773461. eCollection 2021.
PubMed 34988092
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of CytoSorb Therapy in COVID-19 ICU Patients (CTC REGISTRY): Registry of Patient-level Clinical Data on CytoSorb Hemoadsorption Provided Via Integration of the CytoSorb Device Into Extracorporeal Membrane Oxygenation (ECMO), Continuous Renal Replacement Therapy (CRRT), or Hemoperfusion Extracorporeal Circuits in COVID-19 ICU Patients
- ClinicalTrials.gov ID
- NCT04391920
- Acronym / sponsor ID
- CTC REGISTRY / 2020-001
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- CytoSorbents, IncIndustry (pharma, biotech, devices)
- Collaborators
- CytoSorbents Europe GmbH
- Study start
- 28 Aug 2020 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 18 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The CTC Registry collects patient-level clinical data on CytoSorb hemoadsorption provided to COVID-19 ICU patients via integration of the CytoSorb device into ECMO, CRRT, or hemoperfusion extracorporeal circuits. The intent of the registry is to gain understanding on how CytoSorb hemoadsorption provides clinical benefit to COVID-19 ICU patients.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 ICU Patients | – | Device: CytoSorb 300 mL device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COVID-19 ICU patients receiving CytoSorb hemoadsorption via integration of the CytoSorb device into ECMO, CRRT, or hemoperfusion extracorporeal circuits.
Key inclusion criteria (2 listed)
- Confirmed COVID-19
- Provision of CytoSorb therapy per Instructions for Use (IFU) of the CytoSorb device.
Key exclusion criteria (2 listed)
- CytoSorb therapy for diseases other than COVID-19
- Survival unlikely within 24 hours (for prospectively enrolled patients)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CytoSorb 300 mL deviceCytoSorb hemoadsorption provided via integration of the CytoSorb device into ECMO, CRRT, or hemoperfusion extracorporeal circuits. | Device | COVID-19 ICU Patients |
Primary outcome
ICU mortality
Time frame: From the date of start of CytoSorb use until the date of ICU discharge or date of death, whichever comes first, assessed up to 1 year
5 secondary outcomes
Duration of ECMO after start of CytoSorb
Time frame: From the date of start of CytoSorb use until the date of cessation of ECMO or date of death, which ever comes first, assessed up to 1 year
Duration of mechanical ventilatory support after start of CytoSorb
Time frame: From the date of start of CytoSorb use until the date of cessation of mechanical ventilatory support or date of death, which ever comes first, assessed up to 1 year
Duration of pharmacologic hemodynamic support after start of CytoSorb
Time frame: From the date of start of CytoSorb use until the date of cessation of pharmacologic hemodynamic support or date of death, which ever comes first, assessed up to 1 year
Change in serum concentrations of inflammatory biomarkers after start of CytoSorb
Time frame: From the day before start of CytoSorb use until the day after cessation of CytoSorb use
Change in Pa02/Fi02 ratio after start of CytoSorb
Time frame: From the day before start of CytoSorb use until the day after cessation of CytoSorb use
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Derived from this study: PubMed 37337243Hayanga JWA, Song T, Durham L, Garrison L, Smith D, Molnar Z, Scheier J, Deliargyris EN, Moazami N. Extracorporeal hemoadsorption in critically ill COVID-19 patients on VV ECMO: the CytoSorb therapy in COVID-19 (CTC) registry. Crit Care. 2023 Jun 19;27(1):243. doi: 10.1186/s13054-023-04517-3.
- Derived from this study: PubMed 34988092Song T, Hayanga J, Durham L, Garrison L, McCarthy P, Barksdale A, Smith D, Bartlett R, Jaros M, Nelson P, Molnar Z, Deliargyris E, Moazami N. CytoSorb Therapy in COVID-19 (CTC) Patients Requiring Extracorporeal Membrane Oxygenation: A Multicenter, Retrospective Registry. Front Med (Lausanne). 2021 Dec 20;8:773461. doi: 10.3389/fmed.2021.773461. eCollection 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Nelson, MD study director
CytoSorbents Corporation
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by CytoSorbents, Inc at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU mortality (time frame: From the date of start of CytoSorb use until the date of ICU discharge or date of death, whichever comes first, assessed up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04391920, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.